IEC 62304 Software lifecycle frameworks for Software as a Medical Device (SaMD)
Software Validation & Verification in a Box provides a complete set of IEC 62304–aligned software lifecycle documentation templates designed for digital health and software medical device teams.
All documents are provided in editable Word and PDF format and are structured as fill-in-the-blank templates with embedded questions and guidance notes to help you document software development, verification, validation, and maintenance activities in a structured and compliant way.
This package is suitable for teams preparing for regulatory submissions, audits, or internal compliance readiness.
What’s Included
Software Lifecycle Planning
- Software Development Plan (SDP)
- Software Lifecycle Model definition
- Software Safety Classification determination
- Software Development Environment description
Software Requirements & Architecture
- Software Requirements Specification (SRS)
- Software System Architecture description
- Software Detailed Design template
- Interface and data flow documentation
Software Risk Management
- Software Hazard Analysis
- Software Risk Control Measures
- Risk Traceability to requirements and tests
- Residual Software Risk Evaluation
(Aligned with IEC 62304 and ISO 14971 software risk expectations)
Software Verification
- Software Verification Plan
- Unit Testing documentation templates
- Integration Testing documentation templates
- System Testing documentation templates
- Software Verification Report
IEC 62304 Software Validation
- Software Validation Plan
- Software Validation Protocol template
- Software Validation Report
- Validation Summary and conclusions
Traceability
- Software Requirements Traceability Matrix
- Risk–Requirement–Test Traceability Matrix
- Change impact traceability templates
Configuration & Change Management
- Software Configuration Management Plan
- Version and Release Management records
- Software Change Request template
- Change Impact Assessment
- Change Review and Approval records
Maintenance & Problem Resolution
- Software Maintenance Plan
- Problem Resolution procedure
- Bug tracking and resolution records
- Unresolved Anomalies List
Format & Guidance
- Editable Word and PDF documents
- Fill-in-the-blank structure for all templates
- Embedded guidance explaining:
- IEC 62304 requirements
- What level of detail is expected
- How to tailor documentation to your software and risk class
Standards & Frameworks
IEC 62304, ISO 14971, IEC 62366 (as applicable)
Who This Is For
- Digital health and SaMD teams implementing IEC 62304
- Organizations preparing for FDA, EU MDR, or audit review
- Teams needing structured software lifecycle documentation
Scope Clarification
This package provides a standalone IEC 62304–aligned software lifecycle documentation system.
It does not replace an ISO 13485 Quality Management System or regulatory submission-specific documentation.
Ready to document your software lifecycle properly?
Request access to Software Validation & Verification in a Box to receive structured, guided IEC 62304 templates.